760 - Docetaxel, cisplatin, 5-fluorouracil and leucovorin as first-line therapy in advanced gastric cancer (AGC)

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anti-Cancer Agents & Biologic Therapy
Gastric Cancer
Presenter Elena Trusilova
Authors E. Trusilova, N. Besova, V.A. Gorbunova
  • Chemotherapy, N. N. Blokhin Russian Cancer Research Center, 115478 - Moscow/RU

Abstract

Purpose

AGC is relatively chemosensitive, but a standard chemotherapy (CT) regimen has yet to emerge, and responses are of short duration. Docetaxel-containing combinations are new option for pts with AGC. The V325 trial demonstrated the efficacy benefit of adding docetaxel to CF (cisplatim + 5-fluorouracil) (DCF). DCF is associated with significant toxicity, making it less tolerable to pts. We modified the original DCF regimen to reduce its toxicity without decreasing efficacy.

Patients and methods

AGC pts received docetaxel 75 mg/m2 and cisplatin 75 mg/m2 in day2 with leucovorin 50 mg and 5-fluorouracil 500 mg/m2 (3-hour infusion) in day 1-3 every 3w (TPF) instead of original DCF (docetaxel 75 mg/m2, cisplatin 75 mg/m2 in day 1 and fluorouracil 750 mg/m2 in day 1-5 continuous infusion).

Results

39 CT-naïve pts with AGC were included in our study from Feb2008 to Dec2010 (20 female, 19 male). ECOG 0/1/2 were10/80/10% pts. ORR was 40% (16/39), SD – 40% (16/39), PD – 20% (7/39). Median PFS and median OS were evaluated in 38pts and were 5,4m and 9,5m, respectively. Toxicity was moderate. Grade 3 and 4 toxicities included leucopenia – 32,5 and 7,5%, neutropenia – 25 and 40%, thrombocytopenia – 2,5 and 0% pts, febrile neutropenia -1pt (2,5%); asthenia – 2,5 and 0%, stomatitis – 2,5 and 0%, diarrhea – 12,5 and 0%, vomiting – 0 and 2,5% pts. We didn't use G-CSF prophylaxis. There were no deaths and treatment discontinuation due to toxicity. At present 5 pts are still alive, in three of them distant mts disappeared and operation became possible. Their survival is 28,5m (without PD), 32.9m with PD over 10m after surgery and 42m with PD over 12m after surgery.

Conclusion

Our data suggest that TPF regimen has the similar efficacy and better tolerability than the standard DCF. TPF regimen can be safely given in an ambulant setting.

Disclosure

All authors have declared no conflicts of interest.